A Meta‐Analysis of the Safety and Immunogenicity of Pharmacokinetic Similarity Studies and Comparative Clinical Studies

Abstract A biosimilar clinical development program generally includes a pharmacokinetic similarity study and a comparative clinical study. Since both types of studies assess safety and immunogenicity, it is important to evaluate the role of each in determining whether there are any meaningful differences between the proposed biosimilar products and the reference products. We conducted a systematic review and meta‐analysis of the safety and immunogenicity data from pharmacokinetic similarity studies and comparative clinical studies, using a database of approved monoclonal antibody and fusion protein biosimilars. Our analysis showed that pharmacokinetic similarity studies provided valuable information for comparing the immunogenicity and safety of the monoclonal antibody and fusion protein biosimilars with their respective reference products. This work underscores the evolving understanding of these biologics and offers insights into the clinical development of biosimilars.